Trial record 14 of 116 for:    vitamin B12 deficiency

The Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00165711
First received: September 12, 2005
Last updated: December 8, 2005
Last verified: December 2005
  Purpose

Patients who fit the inclusion criteria are admitted into the study. They are given 3 IV injection of MBL in the first week and one tablet three times a day for 16 weeks.


Condition Intervention Phase
Dementia With Vitamin B12 Deficiency
Drug: Mecobalamin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Mattis dementia rating scale

Secondary Outcome Measures:
  • Category fluency test
  • Delirium rating scale
  • CNPI
  • MMSE
  • Plasma homocysteine
  • Plasma isoprostane

Study Start Date: March 2003
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion:

  • Patients with Dementia
  • Serum B12 < 200 pmol/l
  • Serum Homocysteine level > 11.0 micro mol/L

Exclusion:

Significant communication problems

  • deafness, dysarthria, dysphasia etc.
  • unstable DM or hypertension
  • alcohol abuse
  • co-existing diseases which may affect cognition e.g. cognitive cardiac failure, respiratory failure
  • folate < 10 g/dl
  • haemoglobin concentration < 10g/d
  • abnormal thyroid function test or VDRL
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165711

Locations
China, Hong Kong
Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Romeo Chu Eisai Asia Regional Services Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00165711     History of Changes
Other Study ID Numbers: AS-006 (MBL-HKG-05-01)
Study First Received: September 12, 2005
Last Updated: December 8, 2005
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Avitaminosis
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 16, 2014